Platelet rich plasma for knee osteoarthritis - the RESTORE trial
- Conditions
- Musculoskeletal - OsteoarthritisKnee osteoarthritis
- Registration Number
- ACTRN12617000853347
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 288
1)aged greater than or equal to 50 years;
2)knee pain on most days in the last month;
3)tibiofemoral osteophytes on x-ray; and
4)A minimum pain score of 4 on an 11-point numeric rating scale for the last week.
1)Kellgren and Lawrence (KL) grade 1 indicating questionable disease or grade 4 indicating severe disease;
2)predominant lateral tibiofemoral disease;
3)Hyaluronic acid injection in past 6 months, corticosteroid injection in past 3 months or autologous blood product in the past;
4)knee surgery on their most painful knee within past 12 months;
5)systemic or inflammatory joint disease;
6)history of crystalline or neuropathic arthropathy;
7)knee joint replacement or high tibial osteotomy on their most painful knee;
8)plan for joint surgery in next 12 months;
9)other muscular, joint or neurological condition affecting lower limb function;
10)needle phobia;
11)immunosuppression or acute infective processes;
12)cancer or other tumour-like lesions;
13)bleeding disorder or receiving anti-coagulation therapy;
14)presence of a warm tense joint effusion;
15)platelet count greater than or equal to 150,000/microlitre;
16)any other medical condition precluding participation in the study including contraindication to MRI such as pregnancy;
17)be unwilling to discontinue NSAID and other analgesic usage for knee pain, with the exception of paracetamol for rescue pain relief, from 2 weeks prior to baseline assessment until the 12 month follow up assessment;
18)Body mass index (BMI) >40kg/m2 because of problems fitting in to the MRI machine knee coil; and
19)Inability to understand written/spoken English.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall knee pain.<br><br>Scored on an 11-point numerical rating scale for average overall pain in the last week where 0=no pain and 10=worst pain possible.[ Baseline plus 2 months (secondary time point) and 12 months (primary time point) after baseline.<br><br>*Additionally will be asked at 6 and 9 months to identify pattern of pain trajectory.];Medial tibial cartilage volume.<br><br>A MRI will be performed of the study knee using a 3T whole body system with dedicated extremity coil and a T1-weighted fat suppressed 3D gradient recall acquisition sequence.[ Baseline plus 12 months after baseline.]
- Secondary Outcome Measures
Name Time Method